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Completed

NCT Number: NCT04892745

Impact of Hemodialysis on Cutaneo-muscular Electrical Impedance

The primary objective of this pilot study aims to describe the modifications of subcutaneous impedancemetry induced by dialysis.

As secondary objectives, the study aims to 1) describe the modifications of cutaneo-muscular impedancemetry induced by dialysis. 2) describe the relationship between modifications of subcutaneous impedancemetry induced by dialysis and - technical conditions of dialysis; - volemic parameters of dialysis; - evolution of liquid compartments in organism during dialysis; - volemic events or neuromuscular events. 3) describe the relationship between modifications of cutaneo-muscular impedancemetry induced by dialysis and 1) describe the modifications of cutaneo-muscular impedance induced by dialysis. 2) describe the relationship between modifications of subcutaneous impedancemetry induced by dialysis and - technical conditions of dialysis; - volemic parameters of dialysis; - evolution of liquid compartments in organism during dialysis; - volemic events or neuromuscular events.

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Key information

Conditions

Hemodialysis

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Néphrologie, Hôpital Ambroise Paré, APHP

Boulogne-Billancourt, 92100, France

About this study

The study will be realized in dialysis facility of Ambroise Paré hospital, APHP. The duration of enrollment of subjects will be 3 months, each enrolled patient will has 2 or 3 week's follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient ⩾ 18 years;
  • Patient undergoing chronic dialysis in hemodialysis facility of Ambroise Paré hospital;
  • Patient has been informed and given no-opposition for participating to the study.

Exclusion criteria

  • Patient with a pacemaker or an implantable cardioverter defibrillator;
  • Patient under guardianship or curatorship;
  • Foreign patient under french AME scheme.

Treatment and study plan

Primary outcomes

  1. Electrical parameters of subcutaneous impedancemetry

    Time frame: at the end of study, up to 4 months

    Electrical parameter extracellular resistance (Re) will be assessed.

Secondary outcomes

  1. Cutaneo-muscular impedancemetry assessement

    Time frame: at the end of study, up to 4 months

    Cutaneo-muscular impedancemetry will be assessed by extracellular resistance (Re).

  2. Whole body impedancemetry assessement

    Time frame: at the end of study, up to 4 months

    Whole body impedancemetry will be assessed by Re.

  3. Incidence of volemic or neuromuscular events

    Time frame: at the end of study, up to 4 months

    Incidence of volemic or neuromuscular events during the session, such as:

    • peridialytic hypotension,
    • crampses.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: H-ICMUS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 19, 2021
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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